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The current animal-based food systems are being challenged by environmental, social and economic sustainability issues. A systemic transformation from conventional agriculture to a more sustainable cellular agriculture utilising cell-cultivation technologies to produce animal products has been proposed. The aim of this study is to explore the political and policy stakeholders’ perceptions about cellular agriculture; how they perceive of the current food system and its potential transformation into a cellular agricultural system. The qualitative data comprises 13 interviews conducted with representatives of German stakeholders. The data were analysed with the Transformative Innovation Policy approach. Perceptions of the transformative potential of cultured products were classified into drivers and bottlenecks that either advance or hinder the progress of cellular agriculture in Germany. The results show that the political and policy stakeholders are aware of the changes that are needed, but anticipate that large-scale transformation to the cellular agriculture system may not be a plausible solution in the near future.

The global trend towards increased demand for organic food, greener environments, and the integration of biological control agents into pest management strategies has greatly enhanced the need for biopesticides. Biopesticides are made from micro-organisms or other natural substances and are, hence, generally environmentally friendly. However, despite their great potential—and in part due to regulatory challenges—relatively few biopesticides have been registered and commercialised in Nigeria compared to other African countries, such as South Africa and Kenya. Biological active agents are so diverse that applying the same safety standards to all of them is almost impossible. A comparative review of risk assessment processes of Nigeria’s biopesticide regulations with other developing African countries (South Africa and Kenya) and developed regions (the European Union and the United States of America) was conducted. Prolonged field testing, lack of bridged risk assessments, and technical checklists were identified as key factors hampering the research and development of biopesticides in Nigeria. Suitable amendments to the existing regulations guiding biopesticide formulation and utilisation in Nigeria are recommended. Risk assessment matrices for microbial and biochemical pesticides and a scientific/technical checklist have also been developed. It is apparent that harmonisation and data exchange among countries in the region could enhance the advancement of scientific and technical knowledge for sustainable regulation of, and cross-border trade in, biopesticides.

The development of nanotechnology-enabled health products offers innovative therapeutic and diagnostic opportunities to address medical needs. At the moment, no specific regulatory framework exists for such products since they can be covered by the existing frameworks for medicinal products and medical devices. However, these frameworks do require additional guidance to fully cover the particularities of nanotechnology-enabled products. After a detailed analysis of regulatory guidance documents, standards, and scientific publications originating mainly from Europe and the US, the European project “REFINE” has released a White Paper summarising the main needs in the field. The selection of the regulatory pathway, the identification of regulatory information needs, as well as the availability of standardised testing methods are among the identified regulatory challenges. Furthermore, additional guidance is needed on how the similarity of follow-on medicinal products can be demonstrated. Also, challenges related to the classification and assessment of nanotechnology-enabled medical devices are presented. The project consortium is now collecting feedback on the identified challenges through a dedicated survey and published comments on this manuscript. The resulting discussions within the scientific community should help to understand how essential knowledge, methods, tools, and approaches can be obtained with to advance the regulatory science in the area of nanotechnology-enabled health products.

The article provides a description of the Autonomous ship, studies existing relevant projects, and examines the related Operational, Regulatory, and Quality assurance challenges raised due to the development and actual deployment of such vessels in the near future. After reviewing the main operational procedures, existing regulations, and quality assurance standards, a number of possible solutions and approaches to overcome the identified challenges are indicated. Some of the conclusions may be used not only in the Autonomous ships but also in traditionally manned vessels.

The recent proliferation of mobile financial services in developing countries has increased access to financial services among underserved rural and low-income populations. Mobile credit is one emerging mobile financial service that allows consumers to quickly apply for and receive loans over mobile devices. Mobile credit services have achieved early success in Kenya and Tanzania, two mature markets for mobile financial services. While these new services have the potential to further promote financial inclusion, they also raise novel regulatory issues and do not fit neatly into pre-existing regulatory categories. This is due to the nature of mobile credit and the variety of entities and regulatory frameworks implicated in the business models found in these two markets. Policymakers and regulators will need to make choices about how to regulate mobile credit with respect to consumer protection, credit reporting and the use of mobile and mobile money services transactional data, a key input for credit evaluation decisions. These choices will need to take into account promotion of financial inclusion and protection of consumers while limiting disincentives for innovation and investment.

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

Introduction The increasing complexities of conducting multiregional trials and an evolving regulatory environment contribute to unprecedented new challenges for use of patient-reported outcome measures (PROMs) 1 within clinical trials. This paper presents these challenges and potential solutions. Methods Real-world examples and situations are reviewed from an industry and patient-reported outcome (PRO) 2 expert position. Conclusions An increase in the pursuit of new therapeutic targets, changes to the regulatory environment, and business pressures to expand clinical trials to more countries have significantly increased the complexity of confirmatory clinical studies that incorporate PROMs. Decisions to participate in collaborative efforts for endpoint development or proceed independently are made in the context of competing priorities of drug development timelines, drug differentiation strategies, the need for patient-related value messages, and the depth of a sponsor pipeline within specific disease areas. Study logistics are critically important; factors such as concept cultural relevancy, respondent literacy level, and quality of cross-cultural adaptation of PROMs must be evaluated when integrating into confirmatory clinical trials. Awareness of the issues relating to PROs in multiregional studies will enable companies to better plan studies and interpret results.